We’re sure someone said that once, but if not, we’ll be putting a TM on it soon. It’s hard to go through the full legal process to get a trademark, so we’ll likely take the easy way out. Like China. Harsh, maybe. True of the whole country, nope. Scientific reputation is very fragile. You’ve all heard of the Chinese scientist who altered the DNA in vitro of human embryos (who, by the way, is now missing.) A report from Stanford suggests that “a new emphasis on such “constructive vigilance” (towards China) is the best way to begin to protect (US) democratic traditions, institutions, and nation…” China’s CFDA “revealed that between January 2015 and January 2016, 1,184 drug applications (73%) submitted were rejected or withdrawn due to incomplete or fraudulent clinical data.” All this at a time when China is growing its clinical trial capabilities. Repeat after me – “vigilance.”
Take two Peanut M&Ms and call in the morning. No really. That’s how one study participant is keeping up his peanut resistance after building it up during a clinical trial designed to test the effectiveness of a peanut allergy protection therapy. Two-thirds of the kids enrolled in the study were able to consume about two peanuts themselves whereas previously they had experienced severe, sometimes life-threatening reactions to even trace amounts. But now, “These kids can eat enough peanut that parents no longer will have to worry about their teenage daughter kissing someone who’s eaten peanut butter.” Good—parents have enough things to be worried about when their teenage daughter is kissing someone without including anaphylaxis. The FDA gave the drug breakthrough therapy status, so you could see it on the market around now in 2019.
Here’s a good-science headscratcher… The lack of racial diversity in clinical trials is well documented, even in trials for diseases that disproportionately affect ethnic minorities. To the extent Caucasians and ethnic minorities respond differently to drugs, this is bad science. But here’s the headscratcher: minorities more often present with comorbidities (e.g. stroke, hypertension, diabetes) that disqualify them from participation. It seems like these are the drug development and regulatory community’s options: (1) mandate greater minority participation into existing study protocols and likely slow down trials and approvals, (2) mandate greater minority participation and loosen exclusion criteria—making scientific conclusions fuzzier because of comorbidities, (3) change nothing and hope minorities aren’t harmed by the underrepresentation. Send your thoughts here. It’s not an easy topic.
It isn’t often you find real data in conference presentations, but we did. Clinical trials get delayed, no news there. A 2017 report from CenterWatch showed each additional month in a phase III trial added a median expense of $671,000. There are lots of “fixes” out there, but if you’re involved in oncology trials, you’ll find an insightful site start-up presentation from Alicia Williams, Senior Project Manager at MedSource here. InsightCity reached out and asked her “What’s the one thing people should know?” Her response, “The key to improving site start-up time and efficiency lies in proper planning, information sharing, and transparency. Working collaboratively with our sponsors and sites and putting in the preparation to drive timelines leads to success. It’s not easy, but it has a proven track record.” Well said and thanks for not creating another conference presentation that looks like this.
Have you ever participated in a clinical trial?
Treating Alzheimer’s has been a major issue for researchers, considering clinical trials that aim to treat the condition fail at a rate of 99.6 percent. Anything shown to remotely help will lead to big investments, as Biogen and Eisai learned on Thursday when they released positive results on their IND BAN2401. It’s not just a big deal because it could lead to a treatment, but also because it provides evidence we’ve figured out how the condition works. We think Alzheimer’s progresses from amyloid plaque accumulating between neurons, disrupting cell communication. The drug candidate doesn’t clean the plaque up, but it does clean up the cell clusters that form the plaque. Let’s hope this avenue of research provides more answers so we don’t end up spending $1 trillion on the condition by 2050.
The FDA’s Compassionate Use program helps patients that seek access to medications still in the development pipeline. But legislation signed into law this week allows patients to completely bypass the regulatory agency should they so choose. The “Right to Try” bill gives patients access to investigational drugs with the permission of just their physician and the drug manufacturer. It also shields those drug companies from the legal risks involved. Critics, including the American Cancer Society, say the bill gives false hope to patients, and champion the current process of compassionate use and clinical trials. After all, the FDA approves 99% of compassionate use applications, and can even do approvals over the phone. When asked for comment, some formerly prominent musicians said “You gotta fight for your right… to paaaaaaaaarty.”
While Mr. Watson did answer Alexander Graham Bell’s first telephone call, what we’re talking about here is IBM’s Watson. The Mayo Clinic recently released results from a study whereby Watson “in the 11 months after implementation, there was on average an 80% increase in enrollment to Mayo’s systemic therapy clinical trials for breast cancer.” That’s a huge increase given that ~3-5% of cancer patients participate in clinical trials. There’s also a Mayo Clinic radio (yes, there is such a thing) podcast for your listening enjoyment. For those in the clinical development industry, this could be a substantial step in using technology to increase clinical trial participation rates. DYK that IBM’s Watson is named after their first CEO, industrialist Thomas J. Watson? You do now and you’re now less likely to lose on Jeopardy.